益生菌对小儿囊性纤维化患者肺部、胃肠道及生长结局的影响：一项随机对照试验。
The impact of probiotics on pulmonary, gastrointestinal, and growth outcomes in pediatric cystic fibrosis: a randomized controlled trial.
作者信息
Rahmani Parisa, Rohani Pejman, Kariman Arian, Motamed Farzaneh, Modaresi Mohammad Reza, Eftekhari Kambiz, Ayati Mehri, Sohouli Mohammad Hassan
机构信息
Pediatric Gastroenterology and Hepatology Research Center, Pediatrics Centre of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Pediatric Respiratory and Sleep Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
BMC Pediatr. 2025 May 28;25(1):430. doi: 10.1186/s12887-025-05789-0.
OBJECTIVE
Cystic fibrosis (CF) is a fatal hereditary disorder that leads to respiratory infections and gastrointestinal inflammation with possible association with intestinal dysbiosis. The present study was conducted with the aim of investigating the effects of probiotic consumption in improving pulmonary, gastrointestinal, and growth symptoms in patients with CF.
MATERIALS AND METHODS
In this double-blind randomized clinical trial, 110 CF patients were examined. Patients were divided into two equal groups of 55 subjects. Patients in the probiotic group consumed Lactobacillus reuteri at the rate of 10 CFU/d for one month, and the control group received a placebo. Then, pulmonary, gastrointestinal, and growth-related outcomes as well as quality of life were assessed after one month of intervention as well as at three-month follow-up.
RESULTS
The results of our study showed that in both intervention and control groups, weight increases significantly after 12 weeks (P = 0.01). However, no remarkable difference was reported between the two groups after 12 weeks (P = 0.09). In addition, no significant changes were observed between the two groups after 4 and 12 weeks regarding BMI and FEV1. Based on the findings, the score of the CFQ questionnaire in the intervention group increased significantly in the 4th and 12th week. No significant differences were observed between the two groups in terms of factors related to lung function or exacerbations after 12 weeks.The only notable effect reported was related to pain attacks in the probiotic group compared to the placebo group after 4 weeks (P = 0.02).
CONCLUSION
In general, treatment with probiotics improved the quality of life in patients with CF. However, no significant effect was observed on pulmonary, gastrointestinal, and growth-related outcomes.
TRIAL REGISTRATION
This study was retrospectively registered IRCT registration number: IRCT20240105060622N1 (Registration date: 2024-08-16).
目的
囊性纤维化（CF）是一种致命的遗传性疾病，可导致呼吸道感染和胃肠道炎症，可能与肠道菌群失调有关。本研究旨在调查食用益生菌对改善CF患者肺部、胃肠道和生长症状的影响。
材料与方法
在这项双盲随机临床试验中，对110名CF患者进行了检查。患者被分为两组，每组55名受试者。益生菌组患者以10 CFU/d的剂量服用罗伊氏乳杆菌，持续1个月，对照组接受安慰剂。然后，在干预1个月后以及3个月随访时评估肺部、胃肠道和生长相关结局以及生活质量。
结果
我们的研究结果表明，在干预组和对照组中，12周后体重均显著增加（P = 0.01）。然而，12周后两组之间未报告有显著差异（P = 0.09）。此外，4周和12周后，两组在体重指数（BMI）和第1秒用力呼气容积（FEV1）方面未观察到显著变化。根据研究结果，干预组CFQ问卷得分在第4周和第12周显著增加。12周后，两组在肺功能或病情加重相关因素方面未观察到显著差异。唯一值得注意的影响是，与安慰剂组相比，益生菌组在4周后疼痛发作有所改善（P = 0.02）。
结论
总体而言，益生菌治疗改善了CF患者的生活质量。然而，在肺部、胃肠道和生长相关结局方面未观察到显著效果。
试验注册
本研究已进行回顾性注册，伊朗临床试验注册中心注册号：IRCT20240105060622N1（注册日期：2024年8月16日）。
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